Naloxone Hydrochloride
- Product NDC
- 0641-6260
- 11-digit product format
- 006416260
- Labeler code
- 0641
- Product ID
- 0641-6260_531da15c-9a2c-4121-9aa5-85b079d3908b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070299
- Marketing category
- ANDA
- Marketing start
- 2022-03-01
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1659929 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6260-01 | Naloxone Hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 2 |
| 0641-6260-25 | Naloxone Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6260 | NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240411_1bef59b9-7d51-4f19-a054-44b8eb6c6398.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6260-01 | 00641626001 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 0641-6260-25 | 00641626025 | 25 VIAL in 1 CARTON (0641-6260-25) / 1 mL in 1 VIAL (0641-6260-01) | 25 vial | 2022-03-01 | 0000-00-00 | No | No | Current |